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The optimal treatment of superficial venous thrombosis (SVT) is still uncertain. Though low molecular weight heparin (LMWH) is considered the treatment of choice, studies conducted so far do not give clear indications of the optimal dose and duration of treatment. This study aims to evaluate whether an intermediate therapeutic dose of LMWH (parnaparin) is more effective than a prophylactic dose and also to assess whether 10 rather than 30 days are sufficient for treatment.
Outpatients with an episode of SVT of the grand saphenous vein (for at least 4 cm), and/or SVT of the small saphenous vein (for at least 4 cm), and/or SVT of a collateral vein of the large saphenous vein of the thigh (for at least 4cm) are included in this prospective, randomised, double blind, national multicentre study.
Patients will be randomised into double-blind groups to receive (syringes will be identical in appearance) in consecutively numbered boxes:
A - Parnaparin, dose of 8,500 IU aXa taken subcutaneously once a day for 10 days B - Parnaparin, dose of 8,500 IU aXa per day for 10 days followed by Parnaparin 6,400 IU aXa per day for the subsequent three weeks. C - Parnaparin, dose of 4,250 IU aXa per day for 30 days Elastic compression treatment will be recommended with special stocking and/or elastic bandaging with compression to the ankles of 20-40 mmHg, where not contraindicated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | A - Parnaparin 8.500 UI aXa od (therapeutic doses) for 10 days followed by placebo for 20 days |
|
| B | Active Comparator | B - Parnaparin 8.500 UI aXa od for 10 days followed by 6.400 UI aXa once daily (intermediate therapeutic doses) for 20 days |
|
| C | Active Comparator | C - Parnaparin 4.250 UI aXa od (prophylactic doses) for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMWH parnaparin subcutaneously | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary effectiveness objectives | composite of symptomatic and asymptomatic DVT, relapse and/or symptomatic or asymptomatic local extension of SVT and symptomatic PE at 33 days. | 33 days |
| Major bleeding | Bleeding events were defined as major if retroperitoneal, intracranial, intraocular with severe vision damage, intra-articular, intra-abdominal of upper or lower digestive tract, genito-urinary tract, respiratory tract or associated with a decrease in the haemoglobin of ≥ 2.0 g/dL, or if requiring transfusion of ≥2 units of blood or if fatal. Bleeding was classified as minor in all other cases. | 33 |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary effectiveness objectives | i)- reduction in local symptoms during treatment and ii)- the combined efficacy end-point during a follow-up of 93 days after the start of treatment. | 93 |
| secondary outcome for safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gualtiero Palareti, MD | University of Bologna | Study Chair |
| Benilde Cosmi, MD PhD | University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. Angiology & Blood Coagulation; University Hospital S.Orsola-Malpighi | Bologna | BO | 40138 | Italy | ||
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| ID | Term |
|---|---|
| D013924 | Thrombophlebitis |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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the composite of minor haemorrhages, thrombocytopenia or any other adverse events (e.g. local allergic reactions).
| 33 |
| U.O. Medicina Critica |
| Piacenza |
| PC |
| 29100 |
| Italy |
| D002318 |
| Cardiovascular Diseases |
| D010689 | Phlebitis |
| D016491 | Peripheral Vascular Diseases |
| D014657 | Vasculitis |